Does Improvement Towards a Normal Cervical Sagittal Configuration Aid in the Management of Lumbosacral Radiculopathy

Cairo University (CU)

Status: Completed

Conditions: Cervical Lordosis Rehabilitation

Treatments: Other: Traditional treatment; Other: Deneroll cervical extension traction

Study type: Interventional

Funder types: Other

Identifiers

NCT05553002

Cairo-11-2-15

Details and patient eligibility

About

A randomized controlled study with six months follow-up will be conducted to investigate the effects of sagittal head posture correction on 3D spinal posture parameters, back and leg pain, disability, and S1 nerve root function in patients with chronic discogenic lumbosacral radiculopathy . Participants will include 80 patients between 40 and 55 years experiencing chronic discogenic lumbosacral radiculopathy with a definite hypolordotic cervical spine and forward head posture and will be randomly assigned a comparative treatment control group and a study group. Both groups will receive TENS therapy and hot packs, additionally, the study group will receive the Denneroll cervical traction orthotic.

Full description

Despite the fact that there is some evidence of a link between low back pain and head posture , there is limited experimental data to support a cause-and-effect relationship and interventional outcomes. Accordingly, a prospective, randomized, controlled study will be conducted at a research laboratory of our university to investigate if cervical curve restoration and forward head posture correction will have short and long term effects on three dimensional spinal posture parameters as well as lumbar radiculopathy management outcomes such as symptoms, disability, and neurophysiological findings .In this study we will use an orthotic cervical traction termed the Denneroll to help restore normal sagittal spinal configuration based on principles of 3-point bending traction methods. Interventions will be applied at a frequency of 3 times per week for 10 weeks and groups will be followed for an additional 6-months.

Enrollment: 80 patients

Sex: All

Ages: 40 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Absolute rotatory angle less than 25° and greater than 0.
• Anterior head translation distance greater than 15mm
• Confirmed chronic unilateral lumbosacral radiculopathy associated with L5-S1 lumbar disc prolapse .
• Symptoms lasting longer than 3 months

Exclusion criteria

• Previous history of lumbosacral surgery.
• Metabolic system disorder.
• Peripheral neuropathy.
• History of upper motor neuron lesion.
• Spinal canal stenosis.
• Rheumatoid arthritis.
• Osteoporosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Deneroll cervical extension traction

Experimental group

Description:

The study group will receive 3-point bending cervical extension traction following the protocol of Deed Harrison . The duration of each session will start at approximately three minutes and increased one minute per session until reaching the goal of 20 minutes per session

Treatment:

Other: Traditional treatment

Other: Deneroll cervical extension traction

Traditional treatment

Active Comparator group

Description:

The participants will receive hot packs (15 minutes) and TENS therapy to control pain and eliminate the causal role of muscle spasms and/or tightness in changing the posture parameters.

Treatment:

Other: Traditional treatment